FDA Revamping Inspection Planning System, Other Changes: Report
FDA says the Covid-19 health emergency has provided insight into changing inspection activities to the extent it is initiating a new inspection planning system that will be more efficient, transparent, and adaptable to evolving needs. “This will help prioritize high-impact inspections such as those for facilities manufacturing Covid-19 vaccines or ingredients used in multiple critical products, as well as the inspections needed for clinical trials of Covid-19 drugs,” the agency says in a just-released report entitled FDA’s Work to Combat the Covid-19 Pandemic. It says the agency is also developing new approaches to inspect firms utilizing novel advanced manufacturing techniques.
The report highlights numerous activities that occurred during the pandemic, such as reviewing over 700 drug development programs in the planning stages and over 460 clinical trials related to prospective products. On the device side, CDRH reviewed over 8,000 emergency use authorization (EUA) device submissions (more than 5,000 of these for Covid tests), which is 100 times more than in any previous health emergency. The Center also issued EUAs for more than 800 devices (more than 450 of these were tests, including 19 over-the-counter tests.
Additionally, the pandemic highlighted vulnerabilities in the medical supply chain. As a result, CDER’s Drug Supply Chain Surveillance System is being developed to “provide enhanced insight into the drug supply chain — from active ingredient suppliers to clinical settings such as hospitals and pharmacies,” the report says. “This system will utilize existing as well as new data sources to identify early signals that may indicate shortages so they can be prevented and mitigated.”
The agency says CDER was able to work with manufacturers to prevent 482 potential shortages in 2020-2021. It accomplished this in part by expediting review and approval of more than 1,300 manufacturing supplements.
And CDRH’s new Resilient Supply Chain Program (RSCP) program is working to develop and apply state-of-the-art supply chain intelligence to predict and prevent supply shortages. The Center implemented its reporting authority that requires manufacturers to report the shortage of certain medical devices through a new Web-based form. In addition, CDRH integrated internal and external data sources for supply chain analysis and modeling to inform shortage mitigations. “The RSCP has also performed outreach to more than 1,000 manufacturers in 12 countries to perform impact assessments and inform mitigation strategies,” the report says.